Clinical Trial for the Validation of AR Based Neuronavigation System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSeoul National University Hospital
About this trial
The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:
• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.
Participants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older who underwent MRI or CT scan due to brain tumor or cerebrovascular disease
Adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease
Disqualifiers
Cases where application of navigation is not necessary according to the judgment of the researcher or surgeon
When the patient or guardian does not agree
Patients with anatomical deformation due to previous surgery or requiring emergency surgery
Trial design
Design model
Single group
Treatments tested in this trial
AR-based navigation
Diagnostic testThe surgeon will perform all surgical planning and operations with reference to the existing navigation. In this process, the errors of the existing navigation and the newly developed navigation are measured and compared in 3D at several points, and the points are as follows. 1. Fiducial markers 2. Nasion 3. Tumor's margin (anterior, posterior, superior, inferior)
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The degree of 3-dimensional error at each measurement points (mm)
Fiducial markers, nasion
Time frame
6 hours2
The degree of 3-dimensional error at each measurement points (mm) after durotomy
Tumor's margin, ICA bifurcation, et al.
Time frame
6 hoursSecondary outcomes
1
Non-inferiority of AR-based navigation compared to conventional navigation
Statistical comparison of the average value between the error with the actual position of conventional navigation and the error with the actual position of AR navigation.
Time frame
12 months2
Time required to set up and use each navigation
Time required to match conventional navigation and AR navigation, respectively.
Time frame
6 hours3
Economic analysis for each navigation
Economic benefits that can be expected if AR-based navigation can replace conventional navigation will be assessed. Cost for surgery, cost of whole admission period, and hospital day will be evaluated.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: